Junior Validation Engineer

Job Summary Ensures compliance of company operations with all applicable laws, regulations, standards, good business practices, and company documented procedures (including knowledge of all governmental health, occupational, and environmental standards, regulations, and statutes related to the site). Essential Duties and Responsibilities • Develop and maintain validations (IQ, OQ, and PQ) for all SHM processes and equipment. • Achieve specific objectives and goals according to the assigned area. • Identify and execute projects to improve processes and reduce product cost. • Use specialized manufacturing tools (pFMEA, SPC, Lean Manufacturing, Six Sigma, etc.) to resolve issues related to the area. • Document and improve manufacturing processes to develop them according to requirements (Cpk, Gage R&R, T-Test, etc.). • Achieve specific project objectives, as well as resolve chronic problems (product or process transfer) by leading interdisciplinary teams, implementing agendas and reporting adherence and progress. • Complete activities on time to ensure compliance with goals and objectives of the Engineering and Plant department. • Achieve specific objectives and goals according to the assigned area. • Document and improve manufacturing processes to develop them according to requirements (Cpk, Gage R&R, T-Test, etc.). • Achieve specific project objectives, as well as resolve chronic problems (product or process transfer) by leading interdisciplinary teams, implementing agendas and reporting adherence and progress. • Procure, design and validate safe process tools and equipment to reduce losses (scrap, WIP, space, etc.) based on these and other requirements: QRS, ISO 13485. Minimum Qualifications, Education and Experience • 4 years of Bachelor's degree in engineering or similar. 2-5 years of experience or 1-2 years with a postgraduate degree. • 1-3 yrs Medical Device manufacturing experience • Fluent Spanish/English Communication skills (both verbal and written) • Complete understanding and broad application of technical principles, theories and concepts in the field of engineering. General knowledge of disciplines (GPM, GQR, sales and operations)

Location: Baja California, MX

Posted Date: 4/26/2025